DK2358326T3 - PRESSURE AND NON-INVASIVE DEVICES TO SUPPORT THE CIRCUIT AND hemodynamics - Google Patents

Description

The present invention relates to a new device for circulatory assistance.

More particularly it relates to a non-invasive device for circulatory and haemodynamic assistance.

The document US-A-2007/0282233 describes a compression apparatus having an inner and outer layer with an inflatable element arranged within it.

The circulatory system constitutes a closed pressurized hydraulic circuit lined internally with endothelial cells. This endothelium is continually subjected to shear stresses that are essential for maintaining its physiological function: vascular tonicity thanks to the synthesis of nitrogen monoxide, coagulation of the blood, inflammatory response, fight against atherosclerosis, immune system, angiogenesis and apoptosis.

Any pathological alteration of this endothelial function will cause a dysfunction of the system with sometimes dramatic consequences.

Currently, there is no system of circulatory assistance aiming to conserve or to improve this endothelial function.

Known are systems of cardiac assistance that are used to partially or fully replace cardiac activity during surgical operations or to recover this activity when the heart is stopped or to weak. These systems are for the most part invasive systems, they require either the introduction of a tool into the body of a subject, this tool then being used to create pulsations, or the taking of the blood of the subject and the treatment of the blood taken in a bulky machine outside the body and then the injection of the blood into the body of the subject. In all cases, the current systems are costly and complicated to implement since they require the intervention of specialists. Further, these systems can only be implemented at dedicated sites such as medical sites, under the surveillance of qualified people. Also, the existing systems have a complex architecture that makes the manufacture of these systems expensive.

Furthermore, the current systems enable a general intervention to be made in the body of the subject, in general at the level of the subject's heart and do not enable intervention to be made on different parts of a subject's body, such as for example the limbs, hands, the face, or elsewhere.

Thus there is currently no non-invasive system of circulatory assistance intended to preserve the endothelial function or to improve this function when it has been altered.

An object of the present invention is to redress the abovementioned disadvantages.

Another object of the present invention is to propose a non-invasive device for circulatory assistance intended to preserve the endothelial function or to improve this function when it has been altered.

Yet another object of the present invention is to propose a non-invasive device for circulatory assistance, with low cost, simple architecture and simple use.

Another object of the invention is to propose a device for circulatory and haemodynamic assistance capable of being used on any part of a subject such as for example the hands, face, limbs, or feet.

Finally, another object of the invention is to propose a non-invasive system for circulatory assistance that is more effective than the systems of cardiac assistance.

The present invention enables these objects to be achieved with a pulsatile and non-invasive device for circulatory assistance encouraging the circulation of blood volume in the body of a subject, according to the Claim 1.

The device according to the invention enables blood circulation assistance, in a non-invasive way, with the application of pulsation on a part of a subject's body thanks to a multilayer structure.

The device according to the invention is simple to use as it is enough to apply the multilayer structure to one part of the body and to create pulsations that propagate along said part of the body thanks to the pulsation means.

It is not necessary for the subject to move to a dedicated site to use the device of the invention. Indeed, the device of the invention can be used at the subject's home, in a vehicle, when walking or running, during an aircraft flight, etc.

The multilayer structure can be applied to any part of the body, except for sensitive parts such as for example the genital and ocular parts without modifications made in the pulsatile accessories like undergarment with male sex accessories; or pulsatile eye bandage). Thus, the subject can apply the device of the invention to any part of the body, such as for example the face, arm, hand, foot, limb, or neck, to produce circulatory assistance dedicated to this part of the body. Indeed, the device of the invention enables blood circulation assistance to be targeted to part of the body by acting directly on this part of the body. Furthermore, the device of the invention is easy to manufacture and has low cost of manufacture.

Theory

In order to best understand the disturbances of the endothelium in the circulatory system, to be described is the "angiogenesis-apoptosis" interdependence phenomenon in light of the haemodynamic theory based on "Flow and Rate haemodynamic theory" in children and adults and discovered by the inventors.

In the arterial segment, the heart and peristaltic forces push the blood flow in a pulsatile way with differential physiological pressure (between systole and diastole).

However, in the veins and lymph ducts, blood and lymph flow continuously under the action of circulatory forces of different kinds indicated in the: respiratory movements (diaphragm, intercostal muscles), muscular circulatory pump, gravity, atmospheric pressure, cutaneous receptors, viscosity, intervention of the right heart (valves, atrium, ventricle, pulmonary pressure, venous capacitance, pericardium).

Venous drainage is thus directly conditioned by these forces, which ensure its return to the right atrioventricular cavities at the time of diastolic filling.

Good filling of the right heart (or preload) is essential for harmonious operation of the entire cardiovascular system.

Increasing the preload improves the muscular oxygenation of the right ventricle. Indeed, this depends more on diastolic filling than the specific myocardial coronaries. This causes an increase of its contractile force which improves the shear stresses appearing in pulmonary circulation. These will cause a lowering of the vascular resistances because of the excretion of nitrogen monoxide (NO) which they induce in the pulmonary endothelium, and this lowering of the pulmonary resistances (or afterload) in turn improves the overall cardiac flow rate.

This explains why the nitrovasodilators so effective in the treatment of myocardial infarction in the case of left ventricle attack, can on the contrary in the case of right ventricle ischemia risk causing the death of the subject since the filling of this ventricle would decrease in the case of administration because of the vasodilatory action of the nitrites.

Another evocative example, the acrobatic sitting position taken spontaneously by an infant reaches a tetralogy of Fallot. During crisis, because of the increase of pulmonary resistances, the infant becomes blue. By taking this sitting position, the blue infant artificially increases the vascular resistances of the left side which has the effect of diverting a greater pulsatile volume into the pulmonary arterial circuit through the interventricular communication (IVC).

The shear stresses thus increased force the pulmonary endothelium to produce more NO (nitrogen monoxide) which immediately increases flow and rhythm in the pulmonary arterial tree.

As a general rule any increase of the resistances in the hydraulic circuit causes a dysfunction of the injection pump. This explains why the increase of the vascular resistances (afterload) of the left side causes a dysfunction of the left ventricle whose improvement can only come from the lowering of this afterload (vasodilatory action of the nitrites in the case of left infarction).

The right heart in the crisis of Fallot then paradoxically seeks the increase of the left afterload to have its own lowered! This means that it does not hesitate to provisionally imperil the left atrium to improve is own haemodynamic and only then again improve that of the left atrium (Table 1: The Bossy Right Heart)! Currently, in the case of no confidence of the right ventricle, the usual treatment regimen consists in: a) increasing the blood volume with intravenous therapy. b) increasing the atrial kick, with chronotropic effects or with a pacemaker (electric stimulation).

In both cases this is an increase of the shear stresses (volume and rhythm) obtained by non-physiological methods and not free from side effects.

Table 1: Domination of the right heart on the left heart through pulmonary resistances:

1 = Nitrites and Infarction of the Right Ventricle. 2 = Crisis of Fallot.

We consider, unlike the generally accepted concept, that the right heart dominates the development and haemodynamics of the left heart from antenatal life. Indeed during intrauterine life, although the right ventricle (RV) receives 2/3 of body blood volume, the walls of the veins of the right ventricle maintain low remodelling compared with the systemic arteries because of the existence of physiological shunts (ductus venosus, ductus arteriosus, foramen oval).

After birth and because of the closing of the physiological shunts each ventricle receives the same blood volume that is ejected with the same frequency. Subject to identical rheological conditions the right ventricle only represents 1/6 of the myocardial mass of the left ventricle (LV).

This is explained by two main factors: A. Cardiac: Aside from the characteristics already described in the literature (spherical morphology of the right ventricular cavity, distribution of the fibres, contractility axis, etc.) we insist on the major role played by the trabecular muscle that lines the inner anterior face of the right atrium and the largest part of the ventricular cavity (apart from the septum and infundibulum). We have stressed the importance of this concept in our new classification of the right heart divided into five zones. B. Extracardiac: Under the control of the accessory forces detailed below.

In particular we consider that the respiratory pump has a direct effect on the physiological control of the circulatory system.

Extravascular physiological shear stresses influencing the endothelial function A. The "Master" respiratory pump of the cardio-endothelial system:

In the manner of an "Accordion" the lung's inflation/deflation movements create an external shear stress on the pulmonary vasculature. Their impressive effects start after birth with the first breath, which causes an immediate lowering of the pulmonary resistances and starts the closing of the shunts by commencing with the valve of the foramen oval and then in continuation, in a few days, with the ductus venosus and the ductus arteriosus.

Failure of the cavo-pulmonary anastomoses in babies less than 2 years old furthermore relates, according to our clinical experience, to the incapacity of the respiratory pump, because of insufficient development of the muscles of the ribcage, to provide with enough shear stress the required venous drainage. B. Fluctuations/Propaaations of external pulsatile waves causing endothelial reactions:

Similarly, a difference between malign tumours and benign tumours could stem from the presence or not of a capsule that plays a protective role against the propagation of pulsatile waves coming from neighbouring organs. This can explain the more pejorative diagnosis of cancers of the mobile organs (stomach, lungs) as well as tumours of richly vascularized organs like the brain, compared with that of cancers of more fixed organs like the thyroid or prostate.

We explain it bv the fact that anv external stimulation of the endothelial function accelerates angiogenesis and in this case tumour growth Another example: congenital malformations are frequently associated with a reduction during the first months of the pregnancy, the amniotic fluid that isolates the foetus from the pulsatile waves propagated by the neighbouring organs of the mother. {Centre Hospitalo-Universitaire, Strasbourg, France: C. Stoll; et al. Study of 224 Cases of Oligohydramnios and Congenital Malformations in a Series of 225,669 Consecutive Births. Community Genet 1998; 1:71-77}.

The principle on which the present invention is based means dividing the right heart into five morphological zones (ventricular mass and thickness of the vascular walls) according to the response to the shear stresses effected on the endothelial walls. Sayed Nour et al. The Forgotten Driving Forces In Right Head Failure. Asiatic Ann Cardiovasc Thorac Surg. (In Persse).

These five zones are the following:

Zone 1: represented by the venous system, weakly remodelled because of the absence of rhythmic forces. The blood flowing at low pressure in this zone is under the influence of the accessory circulatory forces (Table 1).

Zone 2: represented by the atrio-ventricular cavity, where the venous return blood flow starts to be animated (rhythm and pressure) which causes moderate remodelling. The trabecular muscle here plays a natural braking role attenuating the shear stresses exerted on the wall which allows this to make do with a thickness of 1/6 of that of the left ventricle (which does not have a large trabecular zone). In this zone the haemodynamic depends on the diastolic filling (preload) essential to feed the right ventricular muscle especially in its trabecular part.

Zone 3: This is the interventricular septum which retains normal morphology on the left and on the right, linked to its vascularization by the interseptal arteries. The haemodynamic of this zone depends indirectly on that of the left ventricle (common vascularization) and directly on the shear stresses acting on the right to lower the pulmonary afterload (which causes consecutive haemodynamic improvement on the left).

Zone 4: represented by the infundibulum with very high remodelling resulting from the importance of the shear stresses originating from the first interseptal artery. The haemodynamic of this zone then depends on the shear stresses (volume and rhythm) and the overload of pressure of the first interseptal artery.

Zone 5: represented by the arterial pulmonary tree, little reformed zone, with a wall diameter-thickness percentage almost the same as that of the large veins. The haemodynamic of this zone depends on the vascular resistances (lowering of the afterload), themselves linked to the shear stresses (especially rhythm since the tree manages to lower its arterial pressure, thanks to its compliance, even though it receives the same blood volume as the aorta. Disturbances of the accessory forces can cause endothelial dysfunction. Some examples, according to the previous classification, are mentioned in order to understand the phenomenon:

In Zone 1, highly dependent on these accessory forces, it can be seen that their alterations cause cardiovascular and circulatory disorders almost the same with astronauts and professional divers. Despite the large pressure difference found in these two cases (absent with astronauts, very high with divers) the observed disorders are linked to the failure of the venous drainage pump (high venous capacitance with lack of gravity in space, and with crushing in water).

The same goes for the early development of wrinkles with divers, and severe facial oedema at high altitude (Siobhan Gill, Neil M. Walker, Severe facial oedema at high altitude. Journal of Travel Medicine Volume 200815, Issue 2, Pagesl30 — 132, International Society of Travel Medicine}.

Apart from these extreme conditions, facial oedema around the eyes (inflated eyelids) appears more in the morning after a long night's sleep, (sometimes with headaches) to gradually disappear with the return to activity.

This lymphatic congestion demonstrates the effect of the reduction of gravity on the venous return of the face, causing an accumulation of toxic products (inflammatory syndrome, free radicals, slowing of cavernous circulation).

With infants, however, despite greater vascularization and face area than adults, the effect of gravity during long periods of sleep remains minimal.

The Parkland formula known as the Law of 9s applied in relation to large burns proves the importance of head's body area compared with the rest of the body (18%) with infants against (9%) adults.

Indeed a good sleep favours anabolism (repair and regeneration) of the angiogenesis - apoptosis process which depends on the shear stresses completed by good venous drainage. Whereas, the infant or neonate have very high heart rhythm sometimes double than of an adult (even during sleep).

These shear stresses are thus vital to enable natural acceleration of growth. With such a flow, rhythm and facial area the infant always keeps a smooth face, without the least sign of tumefaction, with a satin skin even after very long periods in supine position.

The morphological difference between adults and infants thus plays an important role in explaining this phenomenon.

In addition, in order to ensure good venous drainage avoiding the side effects caused by gravity during sleep, two other factors operate to complete the action of the accessory forces of circulation: • cries that represent a considerable exercise of the muscular pump for the face prevent venous stasis. • web neck makes venous drainage yet more dependent on the respiratory pump.

Haemodynamic effects in the other zones, Zone 2 to Zone 4, are also disturbed by a reduction of venous returns in Zone 1.

Direct cardio-pathogenic effects (myocardial ischemia or heart malformation) can thus cause major haemodynamic disorders.

Maintaining in Zone 5, a key zone, a good haemodynamic is the condition for good overall operation of the circulatory system. High resistances in Zone 5 (afterload) can cause retrograde haemodynamic disorders with systemic haemodynamic depression. The syndromes of acute or chronic pulmonary hypertension depend on the level of excretion of nitrogen monoxide and vascular remodelling, that is the shear stresses.

In summary, while in physiological conditions the accessory forces of circulation ensure venous and lymphatic drainage, endothelial dysfunction causes venous and lymphatic stasis responsible for circulatory and haemodynamic disorders: signs of fatigue (disorders of the immune system and inflammatory response, early ageing (angiogenesis-apoptosis disorders). It is from these observations that the invention of new devices for circulatory assistance stem. -> to be planned after the last document

SUMMARY 1- In the case of no confidence of the heart pump:

We advise the application of shear frequencies faster than the heart rhythm in Zone 5 (pulmonary artery), for creating a vortex near the arterial wall (rotational flow with energy dissipation under the effect of viscosity - Bernoulli principle) without increasing the pressure (Newton) in order to prevent the compliance or distensibility of the pulmonary artery (terminating with Eisenmenger's syndrome) or in the long term disturbing the monocellular arrangement of the alveolar endothelium.

On the contrary if we use a system of external pulsations acting remotely on Zone 1 like our model of pulsatile trousers, the shear frequencies must be slower than the heart rhythm (no more than 50%) in order not to oversupply with these external compressions, which increase the shear stresses, an already overloaded ventricular and pulmonary circuit. 2- In the case of circulatory risks on a normal heart (astronauts, divers) the frequencies used for the pulsatile suit must be synchronized with the diastolic phase, except in the case of respiratory disorders or tachycardia.

On the peripheral circulation (masks, shoes, boots, etc.) they can be faster than the heart rhythm with no danger. 3 - Finally in the case of cardiac attack, we adapt the shear stresses generated by our pulsatile devices to the needs of the endothelial system according to the relevant part of the circuit.

Applications

The inventors have discovered that the device of the invention can be used for many applications all related to the endothelial function.

The inventors have discovered that ageing, for example, is actually the consequence of a disturbance of the endothelial function implementing a process of angiogenesis-apoptosis interdependence whose early signs like wrinkles or grey hairs appear exactly in one of the most vascularized parts of our bodies (face and head). This ageing is a natural phenomenon linked to the gradual slowing of the process of replacement by angiogenesis of dead cells (programmed cell death or apoptosis) but it is especially accelerated whenever secondary factors (infection, ischemic syndrome, traumatism, X or UV radiation, degenerative syndrome) affect the endothelial function (inflammatory syndrome, immune system, vasoconstriction).

According to an advantageous particularity of the device of the invention, the pulsation means can be adapted to generate pulsations at a rhythm according to: data relative to the heart rhythm, data relative to the breathing rhythm, data relative to the subject's state of health, and/or data relative to the part which the multilayer structure is applied to.

The device of the invention can comprise means for measuring the heart rhythm and means for measuring the breathing rhythm.

The device of the invention can comprise means for modifying, adjusting and selecting the rhythm of pulsations generated by the pulsation means.

The rhythm of pulsations can be determined according to the needs of the subject. Animal experiments carried out by the inventors enable the following cases to be differentiated for the regulation of the rhythm of pulsation according to the state of the subject and according to the area of the body to which is applied the multilayer structure of the device of the invention: in the case of no confidence of the heart pump with the subject: o in the Zone 5, zone of the pulmonary artery, the theory described in the previous "MICROTH" patent and publication which was confirmed by the experiments show that it is necessary to apply a faster shear frequency than the heart rhythm, for creating a vortex near the arterial wall (rotational flow with energy dissipation under the effect of viscosity -Bernoulli's principle) without increasing the pressure (Newton) in order to prevent the compliance or distensibility of the pulmonary artery (terminating with Eisenmenger's syndrome) or disturbing in the long term the monocellular arrangement of the alveolar endothelium, o if the device is used to act on the Zone 1, that is the venous system, for example in the form of pulsatile trousers, the shear frequency must be slower than the heart rhythm, around 50% of the heart rhythm, in order not to oversupply with the external compressions, which increase the shear stresses, an already overloaded ventricular et pulmonary circuit, in the case of circulatory disorders on a normal heart, for example for syndrome X; diabetic or hypertension patients (with no secondary heart effects); side effects of the menopause; astronauts or divers: o the frequency used in the Zone 5 must be synchronized with the diastolic phase, except in the case of respiratory disorders or tachycardia, o on the other peripheral areas, pulsatile masks, shoes or boots, the frequency can be faster than the heart rhythm with no danger.

With normal subjects without heart or circulatory disease, for example with sportspeople: even if athletes are capable of adapting with their venous return (according to the Frank-Starling law of the heart): 1) it is always recommended to monitor the diastolic synchronization, if the environment allows, like in gym or massage rooms. 2) with users like during warm-ups before matches or jogging, an inspection and regular visit by heart specialists in order to set the rules to be followed by the sportsperson.

In summary, medical contact must be maintained regularly to make the correct choice along with haemodynamic improvement: in the case of heart attack, the frequency must be adapted to the needs of the endothelial system according to the zone concerned without synchronization, unlike other applications without heart disease.

In a particular embodiment, the device of the invention can comprise a module including on the one hand selection means allowing a user to select data relative to their physical state, such as age, height, weight, heart condition, the means of measurement of the heart rhythm and the breathing rhythm, and the means to calculate the rhythm of the pulsations according to any of this data according to one or several pre-set relationships.

Advantageously, the inner layer of the multilayer structure can have, on at least one part, a cavity between a microporous wall intended to be put in contact with the subject's skin and a sealed wall of the side of the outer layer, said cavity being arranged to receive, store and/or conduct a product intended to be applied to said subject's skin through said microporous wall.

Thus, the device of the invention enables one or several biological or cosmetic products to be applied and enables their even distribution on the underlying part of the body.

In this case, the multilayer structure of the device of the invention can have an opening for filling the cavity with a product. This opening can when using the device of the invention either be connected to a reservoir of product by a connection means, or be closed in a sealed way by plugging means, said cavity being prefilled and then also serving as product reservoir.

According to a particular embodiment, the multilayer structure can comprise an opening to admit the pulsation fluid coming from the pulsation means, between the inner and outer layers and a gelatinous and/or granular fluid between said outer and inner layers producing the progressive propagation of each pulsation in the direction of the venous return along the part of the body the multilayer structure is applied to.

The gelatinous or granular fluid can according to a particularity of the invention be contained in an intermediate layer between the outer and inner layers.

According to a first version of the pulsation means, the pulsation means can comprise: pneumatic reservoir, compression means of said pneumatic reservoir rhythmically, and sealed connector linking said pneumatic reservoir to the flexible multilayer structure.

The compression means can be mechanical, and actuated by the subject themselves or by an external energy source, portable or not.

According to a second version of the pulsation means, the pulsation means can comprise: prefilled pneumatic reservoir, and sealed connector linking said pneumatic reservoir to the flexible multilayer structure; the reservoir, connector and multilayer structure assembly constituting a closed circuit for the pulsation fluid, and said pneumatic reservoir being arranged so that it is compressed and decompressed by a force exerted by said subject.

This exerted force can be exerted by the subject themselves by closing/opening the wrist when the reservoir is placed in the user's hand.

The force can also be exerted by pressure/depression created by at least one of the subject's shoes striking a surface when walking or running for example. In this case, the prefilled pneumatic reservoir is placed under or in a shoe of the subject so that when the subject exerts a pressure by pressing on their foot, the reservoir is emptied of the fluid it contains and the fluid is injected into the multilayer structure by generating a pulsation and when the subject releases the pressure on their foot, for example by lifting it, the fluid injected into the multilayer structure is recalled into the pneumatic reservoir.

In a particular embodiment, the pneumatic reservoir, connector and flexible multilayer structure can constitute a Monobloc assembly, when for example, the multilayer structure composes a boot intended to be worn by the subject.

The flexible multilayer structure can also comprise a hood intended to be placed on at least one part of the subject's face.

Furthermore, the flexible multilayer structure can comprise trousers.

Advantageously, the flexible multilayer structure can comprise a jacket.

The flexible multilayer structure can also comprise one or several gloves or one part of a glove intended to be applied to at least one part of the subject's hand and/or wrist.

Also, the flexible multilayer structure can comprise a boot, shoe, or sock. In this last case, the pulsation means can be integrated into the sole of the boot, shoe or sock, such that the pulsations are created by the subject's walking or running, the pressures created by pressing the foot on the ground causing the progressive inflation of the multilayer structure, and lifting the foot causing progressive or not deflation of the multilayer structure.

The multilayer structure can comprise: • elements of pulsatile underwear such as corsets, tights, used for example for treating cellulite, or disorders of sexual relations with men and women, • pulsatile rings applicable to the lower or upper limbs with diabetic or hypertension subjects; • orbital accessories, for example in the form of bandage for the eyes for treating wrinkles.

According to another aspect of the invention, an assembly is proposed of non-invasive and pulsatile circulatory assistance covering several parts of a subject's body, said assembly comprising at least several devices according to any one of the previous claims for each of said parts, each of the devices being independent.

According to yet another aspect of the invention, an assembly is proposed of non-invasive and pulsatile circulatory assistance covering several parts of a subject's body, comprising: for each of said parts, a flexible multilayer structure intended to be applied to said part of said subject's body, said structure comprising an inner flexible layer on the side of the said subject's body and a more rigid outer layer, means of pulsation common to said pulsatile structures, said pulsation means being linked in a sealed way to each of said multilayer structures such that, characterized in that said pulsation means are adapted to create pulsations between said inner and outer layers of each of said structures by the intermediary of a "pulsation" fluid, each of said pulsations at the level of each of said parts progressively propagating in the direction of the venous return in said part of said subject's body when said structures are arranged on said subject's body.

Other advantages and characteristics of the invention will appear on examination of the detailed description of an embodiment in no way limiting, and the accompanying drawings in which: FIG. 1 is a schematic representation of an example of multilayer structure implemented in the device of the invention; FIG. 2 is a schematic representation of a console enabling pulsations to be created in the multilayer structure in the multilayer structure of FIG. 1; FIG. 3 is a schematic representation of a compression module enabling pulsations to be created in combination with the console of FIG. 2; FIG. 4 is a schematic representation of a module for determining a rhythm of pulsation; FIG. 5 is a schematic representation of a pulsatile hood according to the invention; and FIG. 6 is a schematic representation of pulsatile trousers according to the invention.

The device of the invention produces rhythmic, harmonious and progressive movements on all or part of the organism by bringing the blood from the extremities to the heart at the time of the diastole. It produces non-aggressive compression forces intended to reduce the venous-lymphatic capacitance often stagnant in the subcutaneous tissues, the hepatic-splenic circulation or the face.

Several examples of the device of the invention will now be described.

In all the examples to be described, the axes of propagation of the "pulsatile waves" are determined so as to conserve the natural and physiological directions of the venous and lymphatic drainages. the pulsatile forces can be produced by a pneumatic system that is electronic, hydraulic or even autonomous, using the subject's own force, and the dorsal parts normally non-inflatable to protect the spine from trauma, can be modified in versions intended for body massage while keeping their essential securities. FIG. 1 is a schematic representation of an example of multilayer structure implemented in the device of the invention.

The multilayer structure 100 represented in FIG. 1 comprises: an inner layer 102 made of elastic material, for example neoprene, polyurethane, latex. a rigid outer layer 104 made up of a rigid material guiding the propagation of the compression waves toward the inside of the body, and an intermediate layer 106 containing a gelatinous fluid enabling the propagation of a wave of progressive pulsatile pressure and toward the heart in the natural and physiological direction of the venous and lymphatic drainage in the part on to which said structure is applied. In the rest of the description it is considered that the natural and physiological direction of the venous and lymphatic drainage is the direction XY shown in FIG. 1.

The multilayer structure 100 also comprises an additional layer 108, comprising a space 110 in biocompatible material, and comprising a microporous wall in contact with the body capable of being filled with a fluid product that is biocompatible and/or biological through a connector 112. This microporous part is in direct contact with the skin. With the pulsations, the product contained in this layer 108 is applied to the subject's body by passing across the microporous part.

The outer layer 104 is linked in a sealed way to the pulsation means (see FIG. 2) to create pulsations in the multilayer structure 100 by means of a connection port 114.

To ensure the progression propagation of the pulsations along the part of the body on to which the multilayer structure 100 is applied, the intermediate layer 106 includes a product with variable consistency, that is gelatinous, granular or other, and distributing each of the pulsations progressively along said multilayer structure in the direction XY. FIG. 2 is a schematic representation of a console enabling pulsations to be created in the multilayer structure 100 of FIG. 1.

The console 200 shown in FIG. 2 comprises: a pneumatic reservoir 202 filled with a fluid, for example inert, gaseous or liquid such as water a sealed connector 204 linking the pneumatic reservoir 202 to the flexible multilayer structure 100.

The sealed connector 204 is directly or indirectly linked to the connection port 114 of the multilayer structure 100.

The pneumatic reservoir 202 can be prefilled. The pneumatic reservoir includes a port 206 for adding, removing or replacing the inert fluid.

The pneumatic reservoir 202 can be directly compressed by the subject themselves. Indeed, this reservoir can be compressed by pressings exerted by the subject's hand.

In one embodiment, the pneumatic reservoir 202 can be arranged under a shoe or under the foot of the subject. The pulsations will then be created during the subject's simple walking or running.

The console 200 can also comprise one or several means of compression of the pneumatic reservoir 202 in a rhythmic manner. The means of compression can be actuated and controlled manually or by a control module. FIG. 3 is a schematic representation of an example of compression module 300 of the pneumatic reservoir 202. The compression module 300 comprises a supply battery 302 and a motor assembly 304 linked to two plates 306 and 308 together forming a space 310 intended to hold the pneumatic reservoir 202. When the motor assembly is actuated the plates 306 and 308 come together then separate in a rhythmic manner. Each coming together of the plates 306 and 308 creates a pressure and each separation a depression. FIG. 4 is a schematic representation of a module for determining the pulsation frequency.

The module 400 for determining the pulsation frequencies comprises a heart rhythm detector 402, a breathing rhythm detector 404, as well as means for inputting data relative to: the subject's state of health, such as for example good health, risk of right heart attack, the subject's corpulence, such as for example height, weight, age, the part on to which the multilayer structure 100 is applied.

In the example shown in the FIG. 4, these input means comprise a touch screen 406.

The module 400 can also comprise a database 408 linked to a computer program 410 which according to the input data determines an adapted pulsation rhythm and transmits a control signal 412 enabling the compression module 300 to be controlled.

Different pulsatile elements of the invention will now be described. FIG. 5 is a schematic representation of a pulsatile hood 500 according to the invention. The pulsatile hood 500 is composed of a facial mask 502 and a collar 504 produced with the multilayer structure 100 shown in the FIG. 1.

The mask 502 has decompression holes 506, at the orbital, buccal, nasal and auricular levels. A connector 114 links the pulsatile console 200 to one or several connection ports 114 arranged on the outer layer of the facial mask 502. Each of the pulsations produced propagates progressively from the connection port 114 toward the bottom/the heart according to a principle axis of propagation shown by the arrow 508. A horizontal axis shown by the arrow 510 represents the path of the pulsatile waves toward the cavernous circuit.

The occipital part 512 of the mask 502 is little or not inflatable. The dorsal part 514 by the neck 516 is arranged to produce a pulsatile massage of the neck in complete safety.

The hood 500 acts as non-invasive and pulsatile circulatory assistance for treating venous-lymphatic stasis of the face and neck. It is worn applied to the face and neck. Its two components, mask 502 and collar 504 operate in rhythmic and regular synchronization and in harmony with the heart-breathing rhythm.

The hood further has the following functions: main function: the restoration and repair of the side effects of endothelial dysfunction with the application of shear stresses synchronized with the diastole, reducing lymphatic and venous congestion; and secondary function: haemodynamic improvement of blood circulation of the cavernous system acting on headaches or memory loss, etc. improvement of the cutaneous circulation by nitrogen monoxide increases and accelerates absorption and penetration of existing cosmetic products such as anti-ageing or skin care products.

The inner layer of the mask 502 can be modelled on a biological mask or in biocompatible material, adapted to the shape of the face and neck. The internal surface can be microporous for the distribution to the skin of fluids with cosmetic nature with or without temperature variation of the products or fluids used, according to indications. Haemodynamic improvement occurs in two steps: immediately by reducing stagnant venous capacitance in synchronization with the diastolicf*) phase. The rhythmic increase of diastolic volume improves ventricular contractility, lowers the pulmonary afterload and improves overall cardiac flow rate; and in the long term, by improving the endothelial function thanks to increased shear stresses: • reduction of the afterload by NO excretion, and • stimulation of the myocardial angiogenesis-cardiogenesis process in the ischemic territory concerned. FIG. 6 is a schematic representation of pulsatile trousers 600 according to the invention.

The pulsatile trousers 600 are composed of a leg part 602, a belt part 604, and a boots part 606. In this version of the invention, the trousers 600 do not include a microporous layer.

The pulsatile waves start at the level of the boots part 606 and come from the pulsatile console 200. Each of the pulsations then propagates toward the heart in an axis shown by the arrow 608.

This system, apart from the functions previously described for the pulsatile hood, has both repair and prophylactic uses: repairing endothelial dysfunction thanks to shear stresses favouring angiogenesis with paraplegic patients, or patients presenting a fracture of the femur; and prophylactic by preventing coagulation disorders linked to endothelial dysfunction with sensitive people for example during a long period of immobilisation such as for example long haul flights, prolonged postoperative supine periods and periods of immobilisation during accidents.

In a particular version, the pulsatile trousers can comprise a first layer in contact with the skin across personal clothing.

Modifications of the dorsal part can be envisaged to provide spinal massage.

The communications between the different parts (trousers, belt, limbs) will be coordinated and synchronized with the diastole, in order to prevent a tourniquet effect at the inguinal crease.

In the same way the following can be envisaged, a pulsatile jacket, pulsatile undergarments, pulsatile boots, pulsatile gloves as well as a complete pulsatile suit. A complete pulsatile suit can also be obtained by assembling a pulsatile hood, jacket, trousers, gloves and shoes. In this case, according to a first embodiment each pulsatile assembly can be combined with dedicated pulsation means. According to a second embodiment, single pulsation means can be used for all the pulsatile assemblies composing the pulsatile suit.

The pulsatile suit can be used for massage purposes. Such a suit considerably improves the Fatigue* related to endothelial dysfunction because of disorders of apoptosis-angiogenesis balance caused by an inflammatory syndrome, immune system deficit, or disturbance of the excretion of nitrogen monoxide.

In a modified version the pulsatile suit can comprise an additional layer in direct contact with the skin, facilitating the distribution of cosmetic products (skin care, tonics, etc.).

The propagation of the pulsatile pulses will be synchronized from several distal origins like the pulsatile boots or gloves.

Each pulsatile assembly can be used separately according to the needs of the subject.

In closed circuit, the pulsatile suit could be used by divers, astronauts, sportspersons and athletes enabling physiological improvement of immediate performance by catecholamine secretion, while in the long term encouraging by angiogenesis the development of muscular mass.

Autonomous pulsatile forces could be obtained with sportspersons from gloves by squeezing the hands or from boots when jogging.

The pulsatile suit can provide assistance to each zone concerned according to the subject's haemodynamic and biophysical needs, that is:

Zone 1 depending on accessory circulatory forces: the pulsatile suit improves the haemodynamic by reducing, by means of the massage waves produced, venous capacitance by encouraging blood return toward the heart at the time of diastole. The invention could benefit the following two groups of indications: • Pathological indications: right ventricle insufficiency, chronic PAH, astronauts, divers, varicose veins, paraplegic patients, orthostatic syndrome. • Comfort indications: massage parlours, fitness, gymnastics, long haul air flights;

Zone 2 to 4 depending on diastolic filling and rhythm: the suit enables subjects suffering serious cardiac pathologies to be ensured of the long term maintenance of this physiological function;

Zone 5: pulmonary arterial tree: The suit lowers resistances and improves the endothelial function.

Each pulsatile device of the invention is a non-invasive device for circulatory assistance enabling a progressive reduction of stagnant venous-lymphatic capacitance. By increasing the preload, the device of the invention improves the cardiac contractility which lowers the afterload causing an overall haemodynamic improvement. In the long term the shear stresses produced by the pulsatile device of the invention will restore and preserve the endothelial function. It transforms the blood stock (venous capacitance of 64%) and its endothelial mass with a natural emergency door in the case of haemodynamic and circulatory failure. This low cost, more physiological method capable of reducing morbidity and mortality is applicable with infants and adults as well as animal subjects.

Naturally, the invention is not limited to the examples that have been described and which illustrate the particular embodiments and are in no way limiting.

Claims (13)

A device for pulsating, non-invasive support for circuits (500, 600) which promote the flow of blood into an individual's body, comprising - a flexible multilayer structure (100) intended to be applied to at least a portion of the individual's body, said structure comprising a flexible inner layer (102) on the side of the subject's body and a more rigid outer layer (104), - pulse means (200, 300, 400) connected to the multilayer structure (100) so that the unit consisting of structure + pulse means is sealed and forming pulse waves between the inner (102) and outer (104) layers by means of a pulsating fluid, the multilayer structure comprising means for guiding each of the pulsations progressively in the direction of venous return toward the interior of the subject's body along the portion of the subject's body when the structure reaches (100) is disposed on this part of the subject's body and the means comprise a gelatinous and / or granular fluid contained in an intermediate layer (106) between the outer layer (10). 4) and the inner layer (102) causes the progressive propagation of each of the pulsations in the direction of venous reflux along the structure (100), and in that the multilayer structure (100) comprises an opening (114) which provides access to pulsating fluid coming from the pulse organs. (200) between the inner (102) and outer (104) layers. Device according to claim 1, characterized in that it further comprises means for determining a pulse rate as a function of: - data relating to the heart rhythm, - data relating to the respiratory rhythm, - data relating to the individual's state of health, and / or - data relating to the part on which the multilayer structure is applied. Device according to any one of the preceding claims, characterized in that the inner layer (102) comprises at least part of a cavity (110) between a microporous wall (108) intended to come into contact with the skin of the individual and a a wall of the side of the outer layer, which cavity (110) is configured to receive and / or guide a product intended to be applied to the subject's skin through the microporous wall (108). Device according to claim 3, characterized in that it comprises an opening (112) for filling the cavity (110) with a product, said opening (112) being tightly closed with obturator means in use. Device according to any of the preceding claims, characterized in that the pulse means (200, 300) comprise: - a pneumatic container (202), - a means (300) for rhythmic compression of the pneumatic container (202), and a tight connector (204) connecting the pneumatic container (202) to the flexible multilayer structure (100). Device according to any one of claims 1 to 4, characterized in that the pulse means comprise: - a pneumatic container (202), - a tight connector (204) connecting the pneumatic container (202) to the flexible multilayer structure (100) ; The unit of container (202), connector (204) and structure (100) providing a closed circuit for the pulsating fluid; and the pneumatic container (202) is arranged to be compressed and decompressed by a force exerted by the individual. Device according to claim 6, characterized in that the container, connector and flexible multilayer structure (100) constitute a compact unit. Device according to any one of the preceding claims, characterized in that the flexible multilayer structure (100) comprises a cap (500) intended to be applied to at least part of the individual's face. Device according to any one of the preceding claims, characterized in that the flexible multilayer structure comprises a pair of pants (600). Device according to any one of the preceding claims, characterized in that the flexible multilayer structure comprises a jacket. Device according to any one of the preceding claims, characterized in that the flexible multilayer structure comprises a glove. Device according to any one of the preceding claims, characterized in that the flexible multilayer structure comprises a boot or a stocking. A pulsating, non-invasive device for supporting the circuit (600) and covering a plurality of an individual's body parts, the device comprising at least one device according to any of the preceding claims for each of these parts.